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Metabolic Signalling in Muscle- and Adipose-tissue Following Insulin Withdrawal and Growth Hormone Injection.

NCT02077348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-02-24

No results posted yet for this study

Summary

Diabetes mellitus type I (DM I) is characterized by lack of endogenous insulin and these patients are 100% dependent on insulin substitution to survive.

Insulin is a potent anabolic hormone with its primary targets in the liver, the skeletal muscle-tissue and - adipose-tissue.

Severe lack of insulin leads to elevated blood glucose levels, dehydration, electrolyte derangement, ketosis and thus eventually ketoacidosis.

Insulin signalling pathways are well-known.

Growth hormone (GH) is also a potent anabolic hormone, responsible for human growth and preservation of protein during fasting. GH (in concert with lack of insulin) induces lipolysis during fasting. It is not known how GH exerts its lipolytic actions.

The aim is to define insulin and growth hormone (GH) signalling pathways in 3 different states in patients with DM I.

And to test whether ATGL-related lipolysis in adipose tissue contributes to the development of ketosis.

1. Good glycemic control
2. Lack of insulin (ketosis/ketoacidosis)
3. Good glycemic control and GH injection

Conditions

  • Diabetes Mellitus Type I
  • Ketoacidosis

Interventions

DRUG

Insulin withdrawal

Withdrawal of usual (evening) insulin, replaced by Insuman Rapid (10% of the amount of usual evening insulin) as a continuous IV- administration overnight until 8 o'clock on the study day.

DRUG

Norditropin

0,4 mg of GH administered at 7.05 A.M. on the study day.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Møller, MD · Aarhus University / Aarhus University Hospital

  • Thomas Voss, MD · Aarhus University / Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02077348 on ClinicalTrials.gov